⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Siemens Healthcare Diagnostics, Inc.: Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;

Medical DevicesSource: FDA (device) · Date: 2026-10-07

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Get alerts for Siemens Healthcare Diagnostics

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Siemens Healthcare Diagnostics, Inc.
Product
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Reason / hazard
The potential for falsely elevated results.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.
Recall initiated
2026-08-17
Code info
Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;
Product quantity
42940 units (3938 US, 39002 OUS)
Voluntary mandated
Voluntary: Firm initiated
City
Tarrytown
State
NY
Country
United States
Event id
99726
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.